Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela

NCT04927871 | Completed

• 1 other identifier: FISPEVEN
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

The American Diabetes Association recommends implementing the Diabetes Prevention Program (DPP) in subjects with prediabetes. In the DPP, weight reduction was the main predictor of a lower incidence of type 2 diabetes (T2D), each kilogram lost was related with 16% lower incidence. However, the effectiveness of the DPP in primary care settings is lower than the original study. A meta-analysis of 36 pragmatic clinical trials of DPP in primary care settings showed a reduction in T2D incidence by 26%, less than half than the original study (58%), with a pooled mean weight loss 1.57 kg higher than standard care, demonstrating the large difficulties to reduce weight of participants at community levels. Total diet replacement (TDR) with low-energy liquid-diet or solid diet (825-853 kcal/day) is an effective strategy to reduce weight. The effectiveness of an intervention including initial rapid weight loss before starting the DPP is ignored in primary care levels in Venezuela. We aim: 1- To compare the weight loss achieved of two lifestyle intervention programs in a community health center of Venezuela: a) A hybrid lifestyle including rapid weight loss with total diet replacement (TDR), then medical nutrition therapy (MNT), and the DPP, VS b) only the DPP; 2- To evaluate the change of cardiometabolic risk factors between groups; 3- To evaluate the implementation process. Our hypothesis is: after six months of intervention, subjects receiving a hybridized lifestyle (TDR+MNT+DPP) will double the weight loss of those that only receive DPP.

Conditions

Obesity; Overweight; PreDiabetes; Diabetes Mellitus, Type 2; Risk Factor, Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Change of weight in kilograms

  The difference of change of weight in kilograms between the arms of the intervention

  6 months

Secondary Outcomes (4)

• Change in the points of Acceptance of the program assessed by a questionnaire using a Likert scale

  6 months

• Change in the points of Appropriateness of the core-curriculum assessed by a questionnaire using a Likert scale

  6 months

• Percentage of Attendance to the program

  6 months

• Percentage of Completion of the program.

  6 months

Study Arms (2)

Hybridized Lyfestile Intervention

EXPERIMENTAL

The participants will receive three interventions including Total Diet Replacement, Medical Nutrition Therapy, and the Diabetes Prevention Program

Behavioral: Total Diet Replacement (TDR); Behavioral: Medical Nutritional Therapy (MNT); Behavioral: Diabetes Prevention Program 4 months

Only Diabetes Prevention Program

ACTIVE COMPARATOR

The comparison group will receive only the Diabetes Prevention Program

Behavioral: Diabetes Prevention Program

Interventions

Total Diet Replacement (TDR) BEHAVIORAL

The nutritionist will provide a total diet replacement (TDR) with Low-Energy Liquid-Diet (LELD - 811 kcal/day, 64 g protein, 132 g carbohydrate, 6 g fat) and the food reintroduction for two months.

Hybridized Lyfestile Intervention

Medical Nutritional Therapy (MNT) BEHAVIORAL

The nutritionist will provide Medical Nutritional Therapy (MNT) using the transcultural Diabetes Nutritional Algorithm (tDNA) Toolkit adapted for Venezuela for four months.

Hybridized Lyfestile Intervention

Diabetes Prevention Program 4 months BEHAVIORAL

The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 4-months.

Hybridized Lyfestile Intervention

Diabetes Prevention Program BEHAVIORAL

The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 6-months.

Only Diabetes Prevention Program

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 20 to 79 years years old
• No personal history of type 2 diabetes
• Body mass index ≥ 25 kg/m2
• High risk for type 2 diabetes

You may not qualify if:

• Chronic ischemic heart disease: acute myocardial infarction, stable angina, unstable angina.
• Stroke.
• Use of anticoagulants
• Severe renal failure
• Heart failure.
• Cannot do moderate-intensity physical activity
• Cannot attend most sessions
• Pregnancy or plans of having during the next sixth months
• Cancer or chemotherapy.
• Use of medications that affect weight (e.g. levothyroxine, pregabalin, orlistat)

Sponsors & Collaborators

• Foundation for Public Health and Epidemiological Research of Venezuela: lead

Study Sites (2)

Maria M. Infante Garcia

Caracas, Chacao, 1006, Venezuela

Location

FISPEVEN

Caracas, Chacao, 1060, Venezuela

Location

MeSH Terms

Conditions

Obesity; Overweight; Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Juan P Gonzalez-R, MD

  Foundation for Public Health and Epidemiological Research of Venezuela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: June 16, 2021
• Study Start: November 16, 2020
• Primary Completion: November 23, 2021
• Study Completion: January 15, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

VE (2)